Standard
In the analysis work, it often demanded to apply high-quality compound with the exact content being accurate in order to be compared as the detection control or used to calibrate the instrument, the compound is known as standard sample.
Standard refers to the standard substance used for measuring the potency of biological products. When the production department submits to a higher authority for approval of the quality standard of the biological product, they should also provide the standard sample (indicated in unit (μ)) used for measuring the potency of the tested product.
According to different application, the verification products can be divided into biological standard for the testing of biological products, endocrine drugs, antibiotics and other bioassay and chemical standards including:
1 chemical standards used for calibration of the instrument;
2 chemical reference standards used for calibration of the ultraviolet or infrared spectrum of the drugs;
3 control standards used for the purity test of drugs as well as the impurity control or as the control standards for content determination of the medicine.
In the page 67 of the appendix in the People's Republic of China Pharmacopoeia 1990 1st edition, we can find hundreds kinds of standards including bornyl ester acetate, eugenol and panaxadiol as well as 39 kinds of control medicine for the purify inspection of traditional Chinese medicine, impurity control or the content determination.
International standards
This refers to standard sample, with the potency units of the existing international standard sample potency units as baseline, undergoing further calibration of its potency units on the basis of a wide range of international cooperation. Its potency is expressed in 1U. For a certain product, for the establishment of the first international standard sample, the determination of its potency units should be consulted and decided by the Committee of Experts before the announcement. The international standard is a standard reference substance for worldwide preparation of national standards, so that the international standards can achieve unity.
Reagents and standards
All reagents in the food analysis laboratories should be clearly labeled to indicate the following: 1 name; 2 the date of preparation; 3 Signature from the people in charge; 4 if necessary, we need to add content such as safety and validity and so on.
Most food analysis should use standard sample as reference for qualitative and quantitative determination. The standard sample should be classified according to the following classification methods: 1 international standard; 2 national standards; 3 internal standard; 4 other standards.
Receptacle for reference standards should be clearly affixed to the label, to indicate the following: 1 name; 2 standard document number; 3 Opening times; 4 Validity; 5 Signature.
In addition, the laboratory should keep all the necessary specific files for all the necessary reference standards.
Capacity analysis standard solution should also be strictly managed. It should be clearly posted on all the standard solution containers with labels to indicate: 1 name; 2 concentration; 3 formulation date; 4 No of formulated procedures; 5 storage conditions; 6 validity; 7 Signature from people in charge.
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- Chemical Name:
- Brivaracetam Impurity 43
- Chemical Name:
- Canagliflozin Impurity 25 Complete Set
- Chemical Name:
- Peramivir Intermediate Impurity 37
- Chemical Name:
- Peramivir Diastereomer Impurity 1
- Chemical Name:
- Vinpocetine impurity 18 drops
- Chemical Name:
- Canagliflozin Impurities 999
- Chemical Name:
- 1,4,8,11-tetraazacyclotetradecane sodium chelation
- Chemical Name:
- Apixaban Impurity D(BMS-719288)+
- Structure:
- Chemical Name:
- 4-Methoxy-2,3,5-trimethylpyride-N-oxide
- CAS:
- 86604-80-0
- MF:
- C9H13NO2
- Chemical Name:
- Peramivir Impurity 26
- Chemical Name:
- Peramivir Impurity 34
- Chemical Name:
- (S)-2-(1-azabicyclo[2.2.2]oct-3-yl)-2,4,5,6-tetrahydro-1H-benz[de]isoquinolin-1-one hydrochloride
- Chemical Name:
- Imatinib impurity BY
- Structure:
- Chemical Name:
- 6β-Methylprednisolone
- CAS:
- 18462-27-6
- MF:
- C22H30O5
- Structure:
- Chemical Name:
- DEXTROMETHORPHAN N-OXIDE
- CAS:
- 1177494-18-6
- MF:
- C18H25NO2
- Structure:
- Chemical Name:
- 1-[(2-CHLOROPHENYL)DIPHENYLMETHYL]-1H-PYRAZOLE
- MF:
- C22H17ClN2
- Structure:
- Chemical Name:
- Celecoxib Impurity 2
- CAS:
- 948293-46-7
- MF:
- C11H9F3N2
- Chemical Name:
- Sugammadex sodium Impurity 45
- Chemical Name:
- Carboprost Trometamol 1
- Chemical Name:
- Apremilast ImpurityTNN
- Structure:
- Chemical Name:
- Tenofovir Impurity 113
- CAS:
- 1335287-28-9
- MF:
- C11H13IN4O
- Chemical Name:
- Cefazolin USP Impurity L-δ3
- Chemical Name:
- Cabozantinib impurity 38
- Chemical Name:
- Cabozantinib impurity 57
- Structure:
- Chemical Name:
- (R)-2-((2R,5R)-3,6-dioxo-5-phenylpiperazin-2-yl)-5-methyl-3,6-dihydro-2H-1,3-thiazine-4-carboxylic acid
- CAS:
- 860011-30-9
- MF:
- C16H17N3O4S
- Chemical Name:
- 6-bromo-4-((dimethylamino)methyl)-5-hydroxy-N,1-dimethyl-2-((phenylthio)methyl)-1H-indole-3-carboxamide
- Chemical Name:
- Dapoxetine impurity 54
- Chemical Name:
- Doxofylline Impurity 21
- Chemical Name:
- Dapoxetine impurity 60
- Structure:
- Chemical Name:
- Bosutinib Impurity 37
- CAS:
- 2095306-27-5
- MF:
- C39H30Cl4N6O6
- Structure:
- Chemical Name:
- ADRENOCHROME
- CAS:
- 54-06-8
- MF:
- C9H9NO3
- Structure:
- Chemical Name:
- TELMISARTAN-D3
- CAS:
- 1189889-44-8
- MF:
- C33H27D3N4O2
- Structure:
- Chemical Name:
- 1-(4-NITRO-PHENYL)-PIPERIDIN-2-ONE
- CAS:
- 39257-91-5
- MF:
- C5H10O2S
- Structure:
- Chemical Name:
- Atomoxetine impurity D CRS
- CAS:
- 873310-29-3
- MF:
- C17H21NO
- Chemical Name:
- Beraprost Impurity 2
- Chemical Name:
- Brivudine Impurity 2
- Structure:
- Chemical Name:
- 3-METHOXYCARBONYLAMINO-4-METHYLPYRIDINE
- CAS:
- 694495-63-1
- MF:
- C8H10N2O2
- Chemical Name:
- Empagliflozin Impurity 74
- Chemical Name:
- Empagliflozin Impurity 78
- Chemical Name:
- Empagliflozin Impurity 85
- Chemical Name:
- Relugolix Impurity 11
- Chemical Name:
- 1-(3,4-bis(hydroxymethyl)-1H-pyrrol-2-yl)ethan-1-one
- Structure:
- Chemical Name:
- Gadobutrol Impurity 32
- MF:
- C14H23GdN4O6
- Structure:
- Chemical Name:
- Olmesartan Medoxomil Impurity 28
- CAS:
- 1127249-17-5
- MF:
- C14H10Br2N4
- Structure:
- Chemical Name:
- Olmesartan Medoxomil Impurity 28
- CAS:
- 1127249-17-5
- MF:
- C14H10Br2N4
- Structure:
- Chemical Name:
- Olmesartan Medoxomil Impurity 28
- CAS:
- 1127249-17-5
- MF:
- C14H10Br2N4
- Structure:
- Chemical Name:
- Olmesartan Medoxomil Impurity 28
- CAS:
- 1127249-17-5
- MF:
- C14H10Br2N4
- Structure:
- Chemical Name:
- Ornidazole Impurity 23
- CAS:
- 1100750-18-2
- Chemical Name:
- Olanzapine impurity CNB
- Structure:
- Chemical Name:
- Pitavastatin Impurity 74
- CAS:
- 167934-30-7
- MF:
- C29H30FNO4
- Chemical Name:
- Canagliflozin Impurity 33
- Structure:
- Chemical Name:
- Loratadine Impurity 14
- CAS:
- 169253-13-8
- MF:
- C22H23ClN2O2
- Structure:
- Chemical Name:
- Metronidazole Impurity 3
- CAS:
- 5006-79-1
- MF:
- C6H7N3O2
- Structure:
- Chemical Name:
- Nifedipine Impurity 9
- CAS:
- 87625-92-1
- MF:
- C15H15NO5
- Structure:
- Chemical Name:
- Peramivir Impurity 7 HCl
- CAS:
- 1352062-19-1
- MF:
- C14H27ClN2O4
- Structure:
- Chemical Name:
- Butylphthalide impurity
- CAS:
- 380905-48-6
- MF:
- C12H16O3
- Structure:
- Chemical Name:
- Dapoxetine impurity
- CAS:
- 2242008-38-2
- MF:
- C30H32ClNO2
- Structure:
- Chemical Name:
- Esomeprazole Impurity 26
- CAS:
- 704910-88-3
- MF:
- C15H15N3OS
- Chemical Name:
- Pregabalin Impurity 25
- Structure:
- Chemical Name:
- Loxoprofen
- CAS:
- 50882-18-3
- MF:
- C7H10O3
- Structure:
- Chemical Name:
- Ropivacaine impurity
- CAS:
- 1543937-58-1
- MF:
- C13H16N2O3
- Structure:
- Chemical Name:
- Mono Oxidation Sugammadex(Org198958-2)
- CAS:
- 2412953-13-8
- MF:
- C72H113NaO49S8
- Structure:
- Chemical Name:
- 3,3'-(oxybis(ethane-1,1-diyl))bis(1,2-dimethylbenzene)
- MF:
- C20H26O
- Structure:
- Chemical Name:
- (R)-3-amino-4-phenyl-1-(3-(trifluoromethyl)-5,6-dihydro-[1,2,4] triazolo[4,3-a]pyrazin-7(8H)-yl)butan-1-one
- CAS:
- 2749805-70-5
- MF:
- C16H18F3N5O
- Structure:
- Chemical Name:
- Amlodipine Impurity 30
- CAS:
- 95574-97-3
- MF:
- C4H7ClO3
- Structure:
- Chemical Name:
- Etoricoxib Impurity 35
- CAS:
- 855307-79-8
- MF:
- C18H13ClN2O2S
- Chemical Name:
- Febuxostat Impurity 102
- Chemical Name:
- Ticagrelor Impurity 131
- Chemical Name:
- door bird impurities
- Chemical Name:
- Topiroxostat Impurity 41
- Structure:
- Chemical Name:
- 2-Piperidinecarboxylic acid, 1-formyl-, (1S,2R,3S,6R,7E,10S,12S)-3-hydroxy-1-[(1E)-2-[(1R,3R,4R)-4-hydroxy-3-methoxycyclohexyl]-1-methylethenyl]-12-methoxy-2,8,10-trimethyl-5-oxo-6-(2-propen-1-yl)-12-[(2R,3S,5R)-tetrahydro-3-methoxy-5-methyl-6-oxo-2H-pyra
- CAS:
- 143210-33-7
- MF:
- C43H69NO11
- Structure:
- Chemical Name:
- Blonanserin Impurity 15
- CAS:
- 143213-96-1
- MF:
- C17H17ClFNO
- Structure:
- Chemical Name:
- 1H-Pyrazole-1-propanoic acid, β-cyclopentyl-4-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-, (βR)-
- CAS:
- 2102675-40-9
- MF:
- C17H19N5O2
- Chemical Name:
- sodium ((S)-4-(4-(2-(2-amino-4-oxo-4,7-dihydro-1H-pyrrolo[2,3-d] pyrimidin-5-yl)ethyl)benzamido)-4-carboxylatobutanoyl)-L-glutamate
- Structure:
- Chemical Name:
- 1H-Purin-2-amine, 6,9-dihydro-9-[(1S,3R,4S)-2-methylene-4-(phenylmethoxy)-3-[(phenylmethoxy)methyl]cyclopentyl]-6-(phenylmethoxy)-N-(triphenylmethyl)-
- CAS:
- 2097265-84-2
- MF:
- C52H49N5O3
- Structure:
- Chemical Name:
- Glycine, N-[(1-ethyl-4-hydroxy-7-phenoxy-3-isoquinolinyl)carbonyl]-
- CAS:
- 808120-20-9
- MF:
- C20H18N2O5
- Chemical Name:
- Vonoprazan Impurity 55
- Chemical Name:
- N-(5-((diphenylphosphoryl)methyl)-4-(2-fluorophenyl)-6-isopropylpyrimidin-2-yl)-N-methylmethanesulfonamide
- Structure:
- Chemical Name:
- Ethane, 1,1,1-trichloro-2,2,2-trimethoxy-
- CAS:
- 19932-79-7
- MF:
- C5H9Cl3O3
- Chemical Name:
- Budesonide Impurity 29
- Chemical Name:
- Budesonide Impurity 20
- Structure:
- Chemical Name:
- 5-Hexenoic acid, 4-(acetylamino)-
- CAS:
- 1824506-31-1
- MF:
- C8H13NO3
- Structure:
- Chemical Name:
- Glycine, N-[(4-methylphenyl)sulfonyl]glycyl-, ethyl ester
- CAS:
- 2478-45-7
- MF:
- C13H18N2O5S
- Structure:
- Chemical Name:
- 1-Pyrrolidinecarboxylic acid, 3-acetyl-4-ethyl-, phenylmethyl ester, (3R,4S)-
- CAS:
- 2411540-29-7
- MF:
- C16H21NO3
- Structure:
- Chemical Name:
- Pneumocandin B0, 1-[(4R,5S)-5-[(2-aminoethyl)amino]-N2-[(10R,12S)-10,12-dimethyl-1-oxotetradecyl]-4-hydroxy-L-ornithine]-
- CAS:
- 1404083-47-1
- MF:
- C52H86N10O16
- Structure:
- Chemical Name:
- 1-Pyrrolidinehexanoic acid, 2-ethenyl-γ,5-dioxo-
- CAS:
- 2512190-67-7
- MF:
- C12H17NO4
- Structure:
- Chemical Name:
- 2-Piperidinone, 3-chloro-1-(4-nitrophenyl)-
- CAS:
- 2512213-45-3
- MF:
- C11H11ClN2O3
- Chemical Name:
- Avatrombopag Impurity 40
- Chemical Name:
- (E)-3-(4-((3-(1-(4-((1H-imidazol-1-yl)methyl)phenyl)-2-carboxyethyl)-1H-imidazol-3-ium-1-yl)methyl)phenyl)acrylate
- Chemical Name:
- Cisatracurium besylate impurity 21
- Chemical Name:
- Dacomitinib Impurity
- Structure:
- Chemical Name:
- 6-O-DESMETHYL DONEPEZIL
- CAS:
- 120013-56-1
- MF:
- C23H27NO3
- Structure:
- Chemical Name:
- 2-(2-METHYL-4-NITRO-IMIDAZOL-1-YL)-ETHANOL
- CAS:
- 705-19-1
- MF:
- C6H9N3O3